SWOG clinical trial number
S1933
A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Open
Phase
Accrual
77%
Abbreviated Title
A Pilot Study of Hypofractionated Radiotherapy Followed by Atezolizumab Consolidation in Stage II or III NSCLC Patients with Borderline Performance Status
Status Notes
This study is open to accrual effective June 15, 2020 at 12:00 p.m. Pacific.
Activated
06/15/2020
Participants
US INSTITUTIONS ONLY, ALL NATIONAL CLINICAL TRIALS NETWORK MEMBERS
Research committees
Lung Cancer
Treatment
Atezolizumab
Other Study Materials
Eligibility Criteria Expand/Collapse
Pathologic (cytological or histological) proof of non-small cell lung cancer (NSCLC).
Stage III NSCLC with Zubrod Performance Status of 2 or Stage II NSCLC with Zubrod Performance Status of 0-2
Must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection.
Must not be candidates for concurrent chemoradiation in the opinion of the treating investigator.
Must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration.
Must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1.
Disease must fit within the radiation constraints detailed in Section 7.2 of protocol in the opinion of a local radiation oncologist.
May have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment.
May have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study.
Must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery.
Must have within 28 days prior to Registration Step 1: ANC >/= 1500/mcl; platelet count >/= 100,000/mcl; hemoglobin >/= 9 grams/dL; total bilirubin </= 1.5 x IULN; AST and ALT </= 2.5 x IULN; serum creatinine </= 1.5 x IULN OR measured or calculated creatinine clearance >/= 40 mL/min.
Must have DLCO of at least 50% documented within 90 days prior to Registration Step 1.
Must not have had a prior history of interstitial lung disease or > Grade 2 (CTCAE Version 5) pneumonitis.
Must not have active autoimmune disease requiring therapy within the past 6 months.
Must not have an active infection requiring therapy.
>/= 18 years old.
Must not be pregnant or nursing.
Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1.
Must be tested for hepatitis B within 28 days prior to randomization. Must not have active (chronic or acute) hepatitis B virus (HBV) infection. May have past or resolved HBV infection.
Must be tested for hepatitis C within 28 days prior to randomization. Must not have active hepatitis C virus (HCV) infection.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible.
Must be offered optional participation in banking of specimens for future research.
Stage III NSCLC with Zubrod Performance Status of 2 or Stage II NSCLC with Zubrod Performance Status of 0-2
Must not be candidates for surgical resection in the opinion of the treating investigator. Participants whose disease was previously resected must have experienced local or regional recurrence at least 12 months after resection.
Must not be candidates for concurrent chemoradiation in the opinion of the treating investigator.
Must have measurable or non-measurable disease documented by CT or MRI. Measurable disease must be assessed within 28 days prior to Registration Step 1. Non-measurable disease must be assessed within 42 days prior to Step 1 registration.
Must have an MRI or CT scan of the brain with contrast within 28 days prior to Registration Step 1.
Disease must fit within the radiation constraints detailed in Section 7.2 of protocol in the opinion of a local radiation oncologist.
May have received prior treatment for their lung cancer, including surgery, chemotherapy, targeted agents, and/or radiation treatment. At least 12 months must have elapsed since last treatment.
May have had prior radiation therapy as long as the irradiated area does not overlap with the radiation field targeted for this study.
Must have recovered from any adverse effects of prior major surgery to the satisfaction of the treating physician. Biopsies and central IV access placement are not considered major surgery.
Must have within 28 days prior to Registration Step 1: ANC >/= 1500/mcl; platelet count >/= 100,000/mcl; hemoglobin >/= 9 grams/dL; total bilirubin </= 1.5 x IULN; AST and ALT </= 2.5 x IULN; serum creatinine </= 1.5 x IULN OR measured or calculated creatinine clearance >/= 40 mL/min.
Must have DLCO of at least 50% documented within 90 days prior to Registration Step 1.
Must not have had a prior history of interstitial lung disease or > Grade 2 (CTCAE Version 5) pneumonitis.
Must not have active autoimmune disease requiring therapy within the past 6 months.
Must not have an active infection requiring therapy.
>/= 18 years old.
Must not be pregnant or nursing.
Participants with known human immunodeficiency virus (HIV) infection must be on effective anti-retroviral therapy and must have undetectable viral load at their most recent viral load test and within 6 months prior to Registration Step 1.
Must be tested for hepatitis B within 28 days prior to randomization. Must not have active (chronic or acute) hepatitis B virus (HBV) infection. May have past or resolved HBV infection.
Must be tested for hepatitis C within 28 days prior to randomization. Must not have active hepatitis C virus (HCV) infection.
No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. Participants with localized prostate cancer who are being followed by an active surveillance program are also eligible.
Must be offered optional participation in banking of specimens for future research.
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Research Committee(s)
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